Duns Number:034442726
Device Description: Kratos Hip Stem, SIZE 13 Lateral Offset, Ti6AI4V Alloy with HA Coating
Catalog Number
AS-213
Brand Name
OrthoMedFlex
Version/Model Number
AS-213
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MEH
Product Code Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Public Device Record Key
9cb5e2a3-ef78-45a0-9f36-304d58132878
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 13, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 371 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 435 |